Tramadol Hydrochloride

Product NDC
10370-223
11-digit product format
103700223
Labeler code
10370
Product ID
10370-223_db277e3d-eeed-4af9-b0a0-c4d561a02737
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA200491
Marketing category
ANDA
Marketing start
2012-06-27
Marketing end
2022-01-31
Substance
TRAMADOL HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-223-11EA - Each10370-2233ac73b2c-ffb3-4325-a25c-2c73c127a1e612013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-223-111037002231130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-223-11) 2012-06-270000-00-00NoNoCurrent